PRRC: meaning of this new role under MDR and IVDR
The Person Responsible for Regulatory Compliance or ‘PRRC’ is a mandatory role introduced by the Medical Device Regulation (MDR), which came into force in May 2021, and the In Vitro Medical Devices Regulation (IVDR), which came into force on the 26th of May 2022.
Article 15 of both regulations announced this with some main clear guidelines on the need to have the necessary PRRC qualifications, requirements and responsibilities listed.
It also indicates who can be designated to take on this role in the case of ‘micro and small enterprises’, as these do not always have the necessary qualified staff. This is one of the topics that will be discussed in this blog post.
Other topics to be discussed are:
- What does the regulation mean by the necessary qualifications?
- When do you need to contact your PRRC?
- What if you need a PRRC and an authorized representative?
Keep on reading if you want to deep dive into the meaning of this new PRRC role with some practical guidance!
PRRC requirements from the MDR and IVDR
Micro and small enterprises
The MDR and IVDR mention “micro and small enterprises”. Why is that? Because many spin-offs and other small manufacturers simply do not have a regulatory person in their workforce. Fortunately, they can outsource this role. But which companies are considered “micro and small”? The MDR and IVDR refer to the “Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises”:- A micro-enterprise has less than 10 employees and less than an annual turnover and/ or annual balance sheet total that does not exceed € 2 million.
- A small enterprise has less than 50 employees and less than an annual turnover and/ or annual balance sheet total that does not exceed € 10 million.
They have the privilege to subcontract a PRRC, who will be continuously and permanently at their disposal.
PRRC qualifications under MDR and IVDR
Who can act as a PRRC? Which experiences are required? The MDR and IVDR state the following:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Neither the regulations nor the guidance document of the MDCG 2019-7 provide interpretations of the other relevant disciplines.
It is clear, however, that the diploma or certificate obtained outside the EU should be recognized by a member of the EU as equivalent to a corresponding qualification in the EU.
PRRC responsibilities under MDR and IVDR
If you are a micro and small business and wish to outsource a PRRC, it is useful to know the exact meaning of the PRRC role, what the responsibilities are and when you should involve them. The role and responsibilities of the PRRC include ensuring:
- the conformity device meets regulatory standards
- technical documentation is established and maintained
- post-market surveillance activities are compliant with regulations
- incidents are recorded and reported and that field safety corrective actions are implemented
- a statement has been issued in case of investigational devices (MDR) or IVD devices intended for use in interventional clinical effectiveness studies (IVDR)
It should be made clear that it is not necessarily up to the PRRC to write the above references. But he must ensure that these requirements are met.
He takes the responsibility for the conformity of the product before the Notified Body or the Competent Authority, but this does not mean that he is the only spokesperson during an audit.
It is up to the manufacturer to inform the PRRC about planned audits, QMS, product changes, any complaints, recalls, or field safety issues. The PRRC is permanently and continuously available to the manufacturer for example in case of unannounced audits.
The PRRC cannot act as an authorized representative. The Medical Device Coordination Group (MDCG) has expressed a desire within the regulations for the authorized representative to add an additional level of scrutiny.
This ensures that the supervision and control of the manufacture of devices, and the relevant post-market surveillance and vigilance activities are carried out in an appropriate manner. If the two roles were fulfilled by the same person, the additional level of scrutiny would be undermined.
For the same reason, the PRRC of a micro or small enterprise and the PRRC of the authorized representative of that same enterprise should not belong to the same external organization.
Conclusion: ensure MDR and IVDR compliance via a PRRC
The introduction of the PRRC under MDR and IVDR brings many questions from manufacturers. What is the meaning of the PRRC and what are the requirements and responsibilities?
For medium and large enterprises, this role can be taken up by a regulatory person on their own payroll. However, for micro and small enterprises, the MDR and IVDR entail additional efforts.
However, this role is intended to ensure that the devices are brought to the market in a safe and effective manner.
Are you in need of a PRRC?
QbD Group already acts as PRRC for many medical device and in-vitro device companies inside and outside the EU. Our experts are there to be counted on and bring their expertise to your company. Need support?